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A Structural HIV Prevention Intervention Targeting High-risk Women

A Structural HIV Prevention Intervention Targeting High-risk Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04413591
Acronym
EMERALD
Enrollment
385
Registered
2020-06-04
Start date
2017-09-14
Completion date
2020-09-22
Last updated
2022-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sex Work

Keywords

Sex work, HIV, STI

Brief summary

The purpose of this study is to assess the effectiveness of a community based combination HIV prevention package, including biomedical, behavioral, and structural services for female sex workers (FSW) in Baltimore, Maryland. This study is a prospective two-group trial comparing the efficacy of a community-based comprehensive HIV/STI prevention package compared to standard of care (HIV testing, counseling, and referrals) among FSWs. Outcomes will be assessed through self-reported illicit drug use and sexual risk behaviors (behavioral) as well as HIV/STI testing (biological).

Detailed description

This study aims: 1. To examine the effect of exposure to community intervention components on HIV/STI risk behaviors (e.g., drug use/unprotected sex), and HIV/STI cumulative incidence over time in FSWs in the intervention (n=275) compared to those in the comparison group (N=175); a. to explore the intervention's effects on the risk environment of exotic dance clubs (N=15) over time 2. To examine how socio-structural (e.g., social cohesion, stigma) and structural vulnerability (e.g., financial and housing stability) indicators change and are associated with the biological and behavioral outcomes over time in FSWs in the intervention (n=275) compared to those in the comparison (n=175) group a. examine the role of these indicators as mediators of the intervention effect on study outcomes; 3. To examine the intervention's implementation through qualitative (e.g., in-depth interviews) and quantitative (e.g., assessment of program fit, reach, facilitators, barriers, program costs) measures. 3.1 To examine participant knowledge of the COVID-19 crisis as well as the impact of the crisis on their mental, and physical well-being.

Interventions

BEHAVIORALCommunity based combination HIV prevention package

The intervention compares the efficacy of a community-based comprehensive HIV/STI prevention package compared to standard of care (HIV testing, counseling, and referrals) among Female Sex Workers.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 or older; * Assigned female at birth and identify with female gender * Have exchanged sex in Baltimore City at least 3 times in the past 3 months; * Willing to undergo testing for HIV, gonorrhea, and chlamydia * Willing to provide locator information.

Exclusion criteria

* Inability to provide informed consent in English; * Women who are determined as too high or drunk; * Women who are cognitively impaired. * Currently enrolled in the SAPPHIRE study

Design outcomes

Primary

MeasureTime frameDescription
Change in HIV/STI cumulative incidence over timeBaseline, 6 month, 12 month, 18 month, 24 month visits.Participants will be tested for HIV, chlamydia and gonorrhea at each study visit.

Secondary

MeasureTime frameDescription
Sexual Risk BehaviorsBaseline, 6 month, 12 month, 18 month visits.Participants will be asked for detailed information about sexual partners in the last 6 months. For each listed partner, the investigators will ask: gender; age; drug use; incarceration history; type of partner (primary, casual, one-time); frequency of sexual activity and condom use; type of sex (oral, vaginal, anal); and if partner had other sexual partners during the time of their sexual involvement. This data collection method allows for calculation of the number of unprotected sexual acts.
Illicit Drug UseBaseline, 6 month, 12 month, 18 month visits.The investigators will ascertain the initiation and frequency of all illicit drugs through the use of a modified NIDA Risk Assessment Battery that has been used and adapted over the past decade.

Other

MeasureTime frameDescription
Implementation evaluation using SPARC Center client satisfaction surveys12-month, 18-monthSPARC Center client satisfaction surveys will be used to determine the fit, facilitators and barriers, quality, and general experience of women who have used the SPARC Center.
Implementation evaluation using in-depth interviews with SPARC staff and clients18 monthsAn in-depth interview guide will be developed by experienced study staff and used to interview SPARC guests and staff with the goal of examining program reach, fit, facilitators and barriers, and program costs.
Implementation evaluation using cross-sectional surveys18 monthsA cross-sectional survey will be developed by study staff and used to determine the reach of the implementation within the FSW community of southwest Baltimore.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026